FDA Advisory Committee votes against risk:benefit profile of frontline anti–PD-1 therapy in metastatic/unresectable ESCC with a PD-L1 expression under 1

“This is probably the best data that we’re going to have. Some of this [decision] is related to how the question was asked. It really asked: Is the risk:benefit profile in favor of [using PD-L1 inhibitors in these patients]? I’m not really sure you can look at this data and say that the answer is yes. Having said that, I do share everybody’s concern that this dataset is still quite small, but I am thankful that this is a minority of patients that are going to be treated.” “I voted no,” Lori Dodd, PhD, of the National Institute of Health in Bethesda, Maryland, said following the vote. “There was no evidence of benefit [with PD-L1 inhibitors] in [patients with PD-L1 expression lower than 1], and in particular, there was evidence of a clear treatment by PD-L1 status interaction…There needs to be more done. I also tried to approach this [decision] as: If we were presented with these data de novo today, would we approve this in this group? There’s just simply not evidence to suggest that it would provide a benefit in this subgroup.” During the meeting, representatives from Merck Sharp and Dohme, Bristol-Myers Squibb, and BeiGene, presented data from the phase 3 KEYNOTE-590 (NCT03189719), CheckMate 648 (NCT03143153), and RATIONALE-306 (NCT03783442) trials, respectively